Compendial Deferrals for USP43-NF38 1S Date: Tue Nov 26 14:00:01 EST 2019 Category Monograph Title Monograph Section Scientific Liaison Revision GENERAL NOTICES TO USP-NF PF 45(1) Pg. ONLINE 2. OFFICIAL STATUS AND LEGAL RECOGNITION, 5. MONOGRAPH COMPONENTS, 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE Climbazole, Iscotrizinol, Epinastine Hydrochloride, Nebivolol Hydrochloride, Ranolazine, E/Etoposide Phosphate:, R/Rivaroxaban:, S/Sevelamer Carbonate:, Regorafenib, R/Rosuvastatin Calcium:, Tetrabenazine, Choline Fenofibrate, Nisoldipine Sujatha Ramakrishna Revision <121> INSULIN ASSAYS PF 43(4) Pg. ONLINE ??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine and Insulin Lispro Diane McCarthy Revision <191> IDENTIFICATION TESTS -- GENERAL PF 45(2) Pg. ONLINE CHEMICAL IDENTIFICATION TESTS/Chloride Lucy Botros Revision <467> RESIDUAL SOLVENTS PF 45(3) Pg. ONLINE 4. LIMITS OF RESIDUAL SOLVENTS/4.2 Class 2: Solvents to Be Limited, 4. LIMITS OF RESIDUAL SOLVENTS/4.3 Class 3: Solvents with Low Toxic Potential, 8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS/8.2 Screening of Water-Soluble Articles, 8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS/8.3 Screening of Water-Insoluble Articles, APPENDICES/Appendix 1: Residual Solvents Included in this General Chapter, APPENDICES/USP Reference Standards 〈 11 〉 Edmond Biba Revision <476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 45(1) Pg. ONLINE INTRODUCTION, IDENTIFICATION OF IMPURITIES, ANALYTICAL PROCEDURES FOR IMPURITIES, REPORTING IMPURITIES, SETTING ACCEPTANCE CRITERIA FOR IMPURITIES, QUALIFICATION OF IMPURITIES, ORGANIC IMPURITIES IN DRUG SUBSTANCES, ORGANIC IMPURITIES IN DRUG PRODUCTS Antonio Hernandez-Cardoso Revision <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND POWDERS--PERFORMANCE QUALITY TESTS PF 44(5) Pg. ONLINE INTRODUCTION, A. DELIVERED-DOSE UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS, C. AERODYNAMIC SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS, INTRODUCTION, A. DELIVERED DOSE UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS AND NASAL SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION- INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINE DEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS, QUANTIFICATION Horacio Pappa Revision <671> CONTAINERS--PERFORMANCE TESTING PF 44(3) Pg. ONLINE INTRODUCTION, MOISTURE VAPOR TRANSMISSION FOR PLASTIC PACKAGING SYSTEMS, CLASSIFICATION SYSTEM FOR PLASTIC PACKAGING SYSTEMS, SPECTRAL TRANSMISSION, GLOSSARY Desmond Hunt Revision <771> OPTHALMIC PRODUCTS - QUALITY TESTS PF 44(5) Pg. ONLINE DRUG PRODUCT QUALITY Margareth Marques Revision <785> OSMOLALITY AND OSMOLARITY PF 44(5) Pg. ONLINE INTRODUCTION, OSMOTIC PRESSUREBACKGROUND, OSMOLALITYOPERATION AND CALIBRATION OF OSMOMETER, OSMOLARITY, MEASUREMENT OF OSMOLALITY, REFERENCES Margareth Marques Revision <941> CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDS BY X-RAY POWDER DIFFRACTION (XRPD) PF 45(1) Pg. ONLINE PRINCIPLES, INSTRUMENT/X-Ray Radiation, QUALITATIVE PHASE ANALYSIS (IDENTIFICATION OF PHASES), QUANTITATIVE PHASE ANALYSIS Kevin Moore New <1042> CELL BANKING PF 44(6) Pg. ONLINE Title, Introduction, 1. INTRODUCTION, 2. GENERAL PROCESSES AND CONSIDERATIONS OF CELL BANKING, 3. PRODUCTION CELL LINE/STRAIN DEVELOPMENT AND RCB GENERATION, 4. CLONALITY, 5. CELL BANK CHARACTERIZATION, 6. CONCLUSION, GLOSSARY, REFERENCES Rebecca Potts Revision <1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 45(1) Pg. ONLINE INTRODUCTION, GLOSSARY/Unspecified impurities and unspecified degradation products:, INTRODUCTION, APPENDICES/Appendix 2: Additional Sources of Information and Guidance Antonio Hernandez-Cardoso
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Compendial Deferrals for USP43-NF38 1S
Date: Tue Nov 26 14:00:01 EST 2019
Category Monograph Title Monograph Section Scientific Liaison
Revision GENERAL NOTICES TO USP-NF PF 45(1) Pg. ONLINE2. OFFICIAL STATUS AND LEGAL RECOGNITION, 5. MONOGRAPH COMPONENTS, 2. OFFICIAL STATUS AND LEGAL RECOGNITION Jessica Simpson
Revision DESCRIPTION AND SOLUBILITY PF 43(4) Pg. ONLINE
4. LIMITS OF RESIDUAL SOLVENTS/4.2 Class 2: Solvents to Be Limited, 4. LIMITS OF RESIDUAL SOLVENTS/4.3 Class 3: Solvents with Low Toxic Potential, 8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS/8.2 Screening of Water-Soluble Articles, 8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS/8.3 Screening of Water-Insoluble Articles, APPENDICES/Appendix 1: Residual Solvents Included in this General Chapter, APPENDICES/USP Reference Standards
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Edmond Biba
Revision<476> CONTROL OF ORGANIC IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 45(1) Pg. ONLINE
INTRODUCTION, IDENTIFICATION OF IMPURITIES, ANALYTICAL PROCEDURES FOR IMPURITIES, REPORTING IMPURITIES, SETTING ACCEPTANCE CRITERIA FOR IMPURITIES, QUALIFICATION OF IMPURITIES, ORGANIC IMPURITIES IN DRUG SUBSTANCES, ORGANIC IMPURITIES IN DRUG PRODUCTS Antonio Hernandez-Cardoso
Revision<601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND POWDERS--PERFORMANCE QUALITY TESTS PF 44(5) Pg. ONLINE
INTRODUCTION, A. DELIVERED-DOSE UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS, C. AERODYNAMIC SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS, INTRODUCTION, A. DELIVERED DOSE UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS AND NASAL SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi
New <621> CHROMATOGRAPHY PF 43(5) Pg. ONLINEDEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS, QUANTIFICATION Horacio Pappa
Revision <785> OSMOLALITY AND OSMOLARITY PF 44(5) Pg. ONLINE
INTRODUCTION, OSMOTIC PRESSUREBACKGROUND, OSMOLALITYOPERATION AND CALIBRATION OF OSMOMETER, OSMOLARITY, MEASUREMENT OF OSMOLALITY, REFERENCES Margareth Marques
Revision<941> CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDS BY X-RAY POWDER DIFFRACTION (XRPD) PF 45(1) Pg. ONLINE
PRINCIPLES, INSTRUMENT/X-Ray Radiation, QUALITATIVE PHASE ANALYSIS (IDENTIFICATION OF PHASES), QUANTITATIVE PHASE ANALYSIS Kevin Moore
New <1042> CELL BANKING PF 44(6) Pg. ONLINE
Title, Introduction, 1. INTRODUCTION, 2. GENERAL PROCESSES AND CONSIDERATIONS OF CELL BANKING, 3. PRODUCTION CELL LINE/STRAIN DEVELOPMENT AND RCB GENERATION, 4. CLONALITY, 5. CELL BANK CHARACTERIZATION, 6. CONCLUSION, GLOSSARY, REFERENCES Rebecca Potts
Revision<1086> IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS PF 45(1) Pg. ONLINE
INTRODUCTION, GLOSSARY/Unspecified impurities and unspecified degradation products:, INTRODUCTION, APPENDICES/Appendix 2: Additional Sources of Information and Guidance Antonio Hernandez-Cardoso
Revision<1092> THE DISSOLUTION PROCEDURE -- DEVELOPMENT AND VALIDATION PF 44(6) Pg. ONLINE
INTRODUCTION, 1. PRELIMINARY ASSESSMENT (FOR EARLY STAGES OF PRODUCT DEVELOPMENT/DISSOLUTION METHOD DEVELOPMENT), 2. METHOD DEVELOPMENT, 3. ANALYTICAL FINISH, 5. VALIDATION, 6. ACCEPTANCE CRITERIA, REFERENCES William Brown
Revision<1102> IMMUNOLOGICAL TEST METHODS -- GENERAL CONSIDERATIONS PF 45(2) Pg. ONLINE
INTRODUCTION, KEY CONSIDERATIONS IN ITM DEVELOPMENT/Reagent Selection, KEY CONSIDERATIONS IN ITM DEVELOPMENT/Development of Immunoassays, VALIDATION/System Suitability or Assay Acceptance Criteria, DATA REPORTING/Trending, DATA REPORTING/Data Tracking Shyamosree Bhattacharya
Revision<1235> VACCINES FOR HUMAN USE -- GENERAL CONSIDERATIONS PF 45(1) Pg. ONLINE
Untitled Section, INTRODUCTION/Regulations and Standards, OVERALL MANUFACTURING PLAN/Manufacturing Facilities and Systems, OVERALL MANUFACTURING PLAN/Manufacturing Process, OVERALL MANUFACTURING PLAN/Manufacturing Surveillance, SEED LOT SYSTEMS/Systems for Biotechnology-Engineered Vaccines, RAW MATERIALS, FERMENTATION, AND CELL CULTURE MEDIA/Untitled Section, MATERIALS OF ANIMAL ORIGIN, SEED LOT SYSTEMS AND CELL BANKING, PROPAGATION AND HARVEST/Propagation and Harvest for Bacterial Vaccines, PROPAGATION AND HARVEST/Propagation and Harvest for Viral Vaccines, PROPAGATION AND HARVEST/Untitled Section, VACCINES PRODUCED BY RECOMBINANT TECHNOLOGY/cell substrate growth phase, VACCINES PRODUCED BY RECOMBINANT TECHNOLOGY/virus production phase, VACCINES PRODUCED BY RECOMBINANT TECHNOLOGY/Untitled Section, PURIFICATION/Bacterial Fermentation, PURIFICATION/Untitled Section, PURIFICATION/Biotechnology-Engineered Cells, PURIFICATION/Viral Vaccines Derived from Chicken Eggs, INTERMEDIATES/Production of Intermediates, INTERMEDIATES/Tests for Intermediates, STERILE FILTERED BULK, FINAL BULK/Tests for Final Bulk, FINAL CONTAINER/Excipients and Other Additives, EVALUATING THE STABILITY OF VACCINES/Stability Protocols, EVALUATING THE STABILITY OF VACCINES/Analytical Measurements, EVALUATING THE STABILITY OF VACCINES/Formal Evaluation of Stability Data and Product Expiry Dating, CONTAINER, LABELING/Container Label, LOT RELEASE TESTING/General Principles, LOT RELEASE TESTING/Common Tests, LOT RELEASE TESTING/Quality, RETENTION SAMPLES AND OTHER REQUIREMENTS, Appendix/Appendix 1: Types of Vaccines Currently Licensed in the U.S. (examples), Appendix/Selected Regulatory Documents Dibyendu Saha
Revision <1238> VACCINES FOR HUMAN USE -- BACTERIAL VACCINES PF 45(1) Pg. ONLINE
Untitled Section, INTRODUCTION, RAW MATERIALS AND MATERIALS OF ANIMAL ORIGIN, CELL BANKS/Source and History, CELL BANKS/Cell Bank Lineage and Genealogy, CELL BANKS/Cell Bank Manufacture, CELL BANKS/Cell Bank Validation, CELL BANKS/Cell Bank Testing, CELL BANKS/Cell Bank Storage, CELL BANKS/Storage Stability, PROPAGATION AND HARVEST/Fermentation Hardware, PROPAGATION AND HARVEST/Product Requirements, PROPAGATION AND HARVEST/Early Development Considerations, PROPAGATION AND HARVEST/Scale-Up, PURIFICATION/Polysaccharide Purification, PURIFICATION/In-Process Controls, PURIFICATION/Untitled Section, PURIFICATION/Protein Purification, INTERMEDIATES, DRUG SUBSTANCE, DRUG PRODUCT AND LOT RELEASE/Other Vaccine Components and Vaccine Properties, DRUG PRODUCT AND LOT RELEASE/Information Insert (Label), DRUG PRODUCT AND LOT RELEASE/Untitled Section, OTHER REQUIREMENTS Dibyendu Saha
New <1239> VACCINES FOR HUMAN USE -- VIRAL VACCINES PF 45(1) Pg. ONLINE
INTRODUCTION/General Categories of Viral Vaccines, RAW MATERIALS AND MATERIALS OF ANIMAL ORIGIN, EGGS AND PRIMARY CELL LINES USED IN VIRAL VACCINE PRODUCTION/Maintenance of Flocks, EGGS AND PRIMARY CELL LINES USED IN VIRAL VACCINE PRODUCTION/Handling of Eggs, EGGS AND PRIMARY CELL LINES USED IN VIRAL VACCINE PRODUCTION/Primary Avian Embryo Cell Lines, EGGS AND PRIMARY CELL LINES USED IN VIRAL VACCINE PRODUCTION/Primary Cell Lines from Other Animal Sources, CELL BANKS AND SEED LOT SYSTEMS/Viral Seed Lots, CELL BANKS AND SEED LOT SYSTEMS/Seed Storage, CELL BANKS AND SEED LOT SYSTEMS/Recombinant Cell Lines, PROPAGATION AND HARVEST, CELL SUBSTRATE GROWTH PHASE, VIRUS PRODUCTION PHASE/In Ovo Cultivation, VIRUS PRODUCTION PHASE/Establishment of Primary Cell Cultures, VIRUS PRODUCTION PHASE/Cell Culture, VIRUS PRODUCTION PHASE/Virus Culture, VIRUS PRODUCTION PHASE/Control Cells During Production, VIRUS PRODUCTION PHASE/Culture Process Technologies and Facility, PURIFICATION/Viral Inactivation, PURIFICATION/Live, Attenuated, and Nonreplicating Viral Vaccines, PURIFICATION/Virus-Derived Subunit Vaccines, PURIFICATION/Recombinant or VLP Vaccines, PURIFICATION/In-Process Controls, INTERMEDIATES/Tests for Intermediates, DRUG SUBSTANCE, DRUG PRODUCT, LOT RELEASE TESTS/Potency Assays, LOT RELEASE TESTS/Common Tests, LOT RELEASE TESTS/Manufacturing Residuals, LOT RELEASE TESTS/Preservatives, LOT RELEASE TESTS/Excipients, LOT RELEASE TESTS/Adjuvants, OTHER INFORMATION, APPENDIX/Selected Regulatory Documents Dibyendu Saha
New<1503> QUALITY ATTRIBUTES OF SYNTHETIC PEPTIDE DRUG SUBSTANCES PF 45(3) Pg. ONLINE
Untitled Section, INTRODUCTION, PEPTIDE DEFINITION, MANUFACTURING METHODS, RAW MATERIALS, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Color and Appearance, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Identification, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Bioassays, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Peptide Content and Assay, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Impurities and Related Compounds, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Microbiological Contamination, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Bacterial Endotoxins, PEPTIDE GENERAL CHARACTERISTICS AND SPECIFICATION/Specific Tests Elena Curti
New <1603> GOOD CASCADE IMPACTOR PRACTICES PF 45(2) Pg. ONLINE
Untitled Section, 1. INTRODUCTION/1.1 Background and Rationale, 1. INTRODUCTION/1.2 Purpose and Scope, 1. INTRODUCTION/1.3 Specific Information Regarding Impactor Stage Mensuration, 2. Definitions of Key Terms Relating to this Chapter, 3. CASCADE IMPACTOR OPERATING PRINCIPLES, 4. APPARATUS MAINTENANCE/4.1 Stage Mensuration, Measurement Traceability, and Mensuration Interval, 4. APPARATUS MAINTENANCE/4.2 Internal Losses, 4. APPARATUS MAINTENANCE/4.3 Inspection of Damaged/Deformed Collection Surfaces, 5. CASCADE IMPACTOR METHOD DEVELOPMENT/5.1 Initial Considerations, 5. CASCADE IMPACTOR METHOD DEVELOPMENT/5.2 Number of Inhaler Actuations/Inhalations per Determination, 5. CASCADE IMPACTOR METHOD DEVELOPMENT/5.3 Number of Replicate APSD Determinations, 5. CASCADE IMPACTOR METHOD DEVELOPMENT/5.4 Mitigation of Particle Bounce and Re-Entrainment, 5. CASCADE IMPACTOR METHOD DEVELOPMENT/5.5 Mitigation of Electrostatic Charge Accumulation, 6. IN-USE ASPECTS/6.1 Initial Considerations, 6. IN-USE ASPECTS/6.2 Inspection of Cascade Impactor Components Susceptible to Deterioration, 6. IN-USE ASPECTS/6.3 Assurance of Stage Collection Surface Coating, 6. IN-USE ASPECTS/6.4 Assertion of Correct Assembly, 6. IN-USE ASPECTS/6.5 Mitigation of Air Leakage into the Apparatus, 6. IN-USE ASPECTS/6.6 Setting of Flow Rate, 6. IN-USE ASPECTS/6.7 Cleaning and Storage Between Uses, 6. IN-USE ASPECTS/6.8 Assertion that Individual Cascade Impactor Assemblies of the Same Type (i.e., Andersen Cascade Impactor or Next Generation Impactor) are Interchangeable Kahkashan Zaidi
New<1604> DATA INTERPRETATION OF AERODYNAMIC PARTICLE SIZE DISTRIBUTION MEASUREMENTS FOR ORALLY INHALED PRODUCTS PF 45(2) Pg. ONLINE
INTRODUCTION/Choice of CI and Sampling Flow Rate for the APSD Measurement, PHARMACOPEIAL APSD DATA ANALYSIS/The Deposition Profile, PHARMACOPEIAL APSD DATA ANALYSIS/The APSD: Sized Deposition Profile, PHARMACOPEIAL APSD DATA ANALYSIS/Stage Grouping of the Deposition Data, OTHER TREATMENTS OF APSD DATA/The APSD: Cumulative Distribution Profile, OTHER TREATMENTS OF APSD DATA/Sized Fractions Kahkashan Zaidi
New<1671> THE DETERMINATION AND APPLICATION OF MOISTURE VAPOR TRANSMISSION RATE PF 44(3) Pg. ONLINE
INTRODUCTION, PACKAGING SYSTEMS, DESICCANT VERSUS WATER MVTR METHOD, EQUIVALENCY AND APPLICATION OF MVTR DETERMINATION METHOD, REPACKAGING OF SODFS, GLOSSARY, REFERENCES Desmond Hunt
New <1711> ORAL DOSAGE FORMS - PERFORMANCE TESTS PF 44(5) Pg. ONLINE Title, INTRODUCTION, DISSOLUTION PROCEDURE DEVELOPMENT, REFERENCES Margareth Marques
New ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS PF 44(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Osmolality and Osmolarity <785>, Osmolality, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baclofen RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Baclofen Related Compound A RS Heather Joyce
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Marmelosin, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Limit of Aegeline, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Aegle marmelos Fruit Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Marmelosin RS Nam-Cheol Kim
New BAEL TREE FRUIT DRY EXTRACT PF 44(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Marmelosin, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Limit of Aegeline, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Aegle marmelos Fruit Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Marmelosin RS Nam-Cheol Kim
New BAEL TREE FRUIT POWDER PF 44(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Marmelosin, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Limit of Aegeline, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Aegle marmelos Fruit Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Marmelosin RS Nam-Cheol Kim
New BITTER ORANGE FRUIT FLAVONOIDS DRY EXTRACT PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavonoids, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bitter Orange Fruit Flavonoids Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Naringin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neohesperidin RS Maria Monagas
New BIVALIRUDIN PF 44(2) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C98H138N24O33, Chemical Info/2180.29 (free base), Chemical Info/l-Leucine, d-phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l-α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α-glutamyl-l-tyrosyl-;, Chemical Info/d-Phenylalanyl-l-prolyl-l-arginyl-l-prolylglycylglycylglycylglycyl-l-asparaginylglycyl-l-α-aspartyl-l-phenylalanyl-l-α-glutamyl-l-α-glutamyl-l-isoleucyl-l-prolyl-l-α-glutamyl-l-α-glutamyl-l-tyrosyl-l-leucine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Amino Acid Content, IDENTIFICATION/D. Bioidentity, ASSAY/Procedure, ??UNKNOWN??/Procedure 1, ??UNKNOWN??/Procedure 2, OTHER COMPONENTS/Trifluoroacetic Acid (TFA) in Peptides <503.1>, SPECIFIC TESTS/Microbial Enumeration Tests <61>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [des-Glu13]-Bivalirudin RS Elena Curti
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Bioidentity, ASSAY/Procedure, ??UNKNOWN??/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, SPECIFIC TESTS/Completeness of Solution <641>, SPECIFIC TESTS/Constituted Solution, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bivalirudin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP [Asp9]-Bivalirudin RS Elena Curti
Revision BROMOCRIPTINE MESYLATE CAPSULES PF 43(6) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck
New BUDESONIDE NASAL SPRAY PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Potassium Sorbate, OTHER COMPONENTS/Content of Edetate Disodium, PERFORMANCE TESTS/Delivered-Dose Uniformity, PERFORMANCE TESTS/Minimum Fill <755>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Edetate Disodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Potassium Sorbate RS Richard Nguyen
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupropion Hydrochloride Related Compound C RS Note-May also be labeled as USP Bupropion Hydrochloride Related Compound C RS., ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Bupropion Hydrochloride Related Compound F RS Note-May also be labeled as USP Bupropion Hydrochloride Related Compound F RS. Heather Joyce
Revision CEFEPIME FOR INJECTION PF 44(2) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Procedure 2, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane
Revision CEFIXIME PF 44(1) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Optical Rotation <781S>, Procedures, Specific Rotation Slavica Shane
New CEFIXIME CAPSULES PF 44(1) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Ultraviolet Absorption <197U>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Cefixime RS Slavica Shane
Revision CEFIXIME FOR ORAL SUSPENSION PF 44(1) Pg. ONLINE
IDENTIFICATION/ A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62> Slavica Shane
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination, Method I <921>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage Slavica Shane
Revision CEFOTETAN FOR INJECTION PF 43(6) Pg. ONLINE
IDENTIFICATION/B. Identification Tests-General, Sodium <191>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling <7>, Labels and Labeling for Injectable Products, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Slavica Shane
Revision CEFOTETAN DISODIUM PF 43(6) Pg. ONLINE
IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Slavica Shane
Revision CEFTAZIDIME PF 45(3) Pg. ONLINE
CHEMICAL INFORMATION, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Pyridine, SPECIFIC TESTS/Bacterial Endotoxins Test ⟨
Revision CEFTAZIDIME FOR INJECTION PF 45(3) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Sodium Carbonate (Where Present), OTHER COMPONENTS/Content of Arginine (Where Present), IMPURITIES/Organic Impurities, IMPURITIES/Limit of Pyridine, SPECIFIC TESTS/Bacterial Endotoxins Test
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85
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:, SPECIFIC TESTS/Sterility Tests
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71
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:, SPECIFIC TESTS/Loss on Drying
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731
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, ADDITIONAL REQUIREMENTS/Packaging and Storage:, ADDITIONAL REQUIREMENTS/USP Reference Standards
IDENTIFICATION/Infrared Absorption <197K>, IDENTIFICATION/C., IDENTIFICATION/C. Identification Tests-General <191>, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP 2-Amino-5-chlorobenzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Chlordiazepoxide Related Compound A RS Heather Joyce
New CHLOROMETHYLNITROIMIDAZOLE PF 43(3) Pg. ONLINE Chloromethylnitroimidazole Sridevi Ramachandran
DEFINITION/Untitled Section, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin ⟨
203
⟩
, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Limits of Elemental Impurities:, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Pesticide Residue Analysis:, CONTAMINANTS/Articles of Botanical Origin
⟨
561
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, Test for Aflatoxins:, CONTAMINANTS/Microbial Enumeration Tests
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2021
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:, CONTAMINANTS/Absence of Specified Microorganisms
⟨
2022
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, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Foreign Organic Matter:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Alcohol-Soluble Extractives, Method 1:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Water-Soluble Extractives, Method 2:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Total Ash:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Acid-Insoluble Ash:, SPECIFIC TESTS/Loss on Drying
DEFINITION/Untitled Section, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin ⟨
203
⟩
, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Limits of Elemental Impurities:, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Pesticide Residue Analysis:, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Test for Aflatoxins:, CONTAMINANTS/Microbial Enumeration Tests
⟨
2021
⟩
:, CONTAMINANTS/Absence of Specified Microorganisms
⟨
2022
⟩
, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Alcohol-Soluble Extractives, Method 1:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Water-Soluble Extractives, Method 2:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Total Ash:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Acid-Insoluble Ash:, SPECIFIC TESTS/Loss on Drying
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Beclomethasone Dipropionate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clobetasol Propionate Related Compound A RS Mary Koleck
New CLOBETASOL PROPIONATE TOPICAL SPRAY PF 45(1) Pg. ONLINE
DEFINITION, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Alcohol, OTHER COMPONENTS/Content of Isopropyl Myristate, PERFORMANCE TESTS/Delivered-Dose Uniformity, PERFORMANCE TESTS/Minimum Fill
⟨
755
⟩
:, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests
⟨
61
⟩
and Tests for Specified Microorganisms
⟨
62
⟩
:, ADDITIONAL REQUIREMENTS/Packaging and Storage:, ADDITIONAL REQUIREMENTS/USP Reference Standards
⟨
11
⟩
Mary Koleck
Revision CLONAZEPAM PF 44(3) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K> or <197A>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Clonazepam Related Compound C, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Clonazepam Related Compound C RS Heather Joyce
DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Readily Carbonizable Substances Test <271>, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Melting Range or Temperature, Class I <741>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Sterility Tests <71>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Endotoxin RS Behnaz Almasi
ASSAY/Procedure, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Dicyclomine Related Compound A, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Dicyclomine Related Compound A RS Behnaz Almasi
Chemical Info/296.54296.52, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K><197>, ASSAY/Procedure, IMPURITIES/<291>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I <741> Heather Joyce
Revision DOXAZOSIN TABLETS PF 44(5) Pg. ONLINE
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxazosin Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Doxazosin Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terazosin Related Compound A RS Edith Chang
Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Sterility Tests <71>, Test for Sterility of the Product to be Examined, Membrane Filtration, SPECIFIC TESTS/Particulate Matter in Ophthalmic Solutions <789>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Edetate Disodium RS Brian Serumaga
IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluphenazine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Fluphenazine Related Compound B RS Heather Joyce
Revision FORMOTEROL FUMARATE PF 45(3) Pg. ONLINE
CHEMICAL INFORMATION, IDENTIFICATION/A. Spectroscopic Identification Tests 197 , Infrared Spectroscopy:, ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Formoterol Related Compound I, ADDITIONAL REQUIREMENTS/USP Reference Standards
⟨
11
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Ravi Ravichandran
New GADOTERATE MEGLUMINE INJECTION PF 44(3) Pg. ONLINE
Chemical Info/Chemical Structure, Chemical Info/C16H25GdN4O8·C7H17NO5, Chemical Info/753.86, Chemical Info/d-Glucitol, 1-deoxy-1-(methylamino)-, [1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-&kgr;N1,&kgr;N4,&kgr;N7,&kgr;N10,&kgr;O1,&kgr;O4,&kgr;O7,&kgr;O10]gadolinate(1-) (1:1);, Chemical Info/1-Deoxy-1-(methylamino)-d-glucitol hydrogen [1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetato(4-)-&kgr;N1,&kgr;N4,&kgr;N7,&kgr;N10,&kgr;O1,&kgr;O4,&kgr;O7,&kgr;O10]gadolinate(1-), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Meglumine, IMPURITIES/Limit of Free Gadolinium, IMPURITIES/Limit of Free Tetraxetan, SPECIFIC TESTS/pH <791>, SPECIFIC TESTS/Particulate Matter in Injections <788>, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Container Content for Injections <697>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Gadoterate Meglumine RS Ravi Ravichandran
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test 201 , IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Berberine, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Berberine Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Berberis aristata Stem Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Palmatine Chloride RS Nam-Cheol Kim
New INDIAN BARBERRY STEM DRY EXTRACT PF 44(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Berberine, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Berberine Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Berberis aristata Stem Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Palmatine Chloride RS Nam-Cheol Kim
New INDIAN BARBERRY STEM POWDER PF 44(5) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Berberine, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Berberine Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Berberis aristata Stem Dry Extract RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Palmatine Chloride RS Nam-Cheol Kim
OTHER COMPONENTS/Zinc Determination <591>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Labeling Manoj Metta
New ISCOTRIZINOL PF 43(5) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C44H59N7O5, Chemical Info/765.98, Chemical Info/Benzoic acid, 4,4′-[[6-[[4-[[(1,1-dimethylethyl)amino]carbonyl]phenyl]amino]-1,3,5-triazine-2,4-diyl]diimino]bis-, bis(2-ethylhexyl) ester;, Chemical Info/Bis(2-ethylhexyl) 4,4′-[(6-{[4-(tert-butylcarbamoyl)phenyl]amino}-1,3,5-triazine-2,4-diyl)diimino]dibenzoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ethylhexyl Triazone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Iscotrizinol Related Compound I RS Feiwen Mao
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavonol Glycosides and Quercetin, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isorhamnetin-3-O-Rutinoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Quercetin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rutin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sophora japonica Flower Dry Extract RS Cuiying Ma
New JAPANESE SOPHORA FLOWER DRY EXTRACT PF 44(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavonol Glycosides and Quercetin, CONTAMINANTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Pesticide Residues, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Loss on Drying <731>, SPECIFIC TESTS/Botanical Extracts <565>, Preparations, General Pharmacopeial Requirements, Residual Solvents, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isorhamnetin-3-O-Rutinoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Quercetin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rutin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sophora japonica Flower Dry Extract RS Cuiying Ma
New JAPANESE SOPHORA FLOWER POWDER PF 44(6) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin <203>, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Flavonol Glycosides and Quercetin, CONTAMINANTS/Articles of Botanical Origin <561>, Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin <561>, Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin <561>, Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests <2021>, CONTAMINANTS/Absence of Specified Microorganisms <2022>, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Isorhamnetin-3-O-Rutinoside RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Quercetin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Rutin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sophora japonica Flower Dry Extract RS Cuiying Ma
New LACOSAMIDE PF 45(3) Pg. ONLINE
CHEMICAL INFORMATION, DEFINITION, IDENTIFICATION/A. Spectroscopic Identification Tests
⟨
197
⟩
, Infrared Spectroscopy:, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition
⟨
281
⟩
:, IMPURITIES/Limit of Lacosamide S-Enantiomer, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination
DEFINITION, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH 791 :, SPECIFIC TESTS/Particulate Matter in Injections
⟨
788
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:, SPECIFIC TESTS/Sterility Tests
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71
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:, SPECIFIC TESTS/Bacterial Endotoxins Test
⟨
85
⟩
:, ADDITIONAL REQUIREMENTS/Packaging and Storage:, ADDITIONAL REQUIREMENTS/USP Reference Standards
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Calcium, IMPURITIES/Limit of Lead, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision MAGNESIUM OXIDE PF 43(6) Pg. ONLINEIDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Calcium, ADDITIONAL REQUIREMENTS/USP Reference Standards <11> Michael Chang
Revision METHYLENE BLUE INJECTION PF 45(1) Pg. ONLINE
DEFINITION/Untitled Section, ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Azure B, SPECIFIC TESTS/Bacterial Endotoxins Test 85 :, SPECIFIC TESTS/Sterility Tests
Title, Chemical Info/Chemical Structure, Chemical Info/C22H25F2NO4·HCl, Chemical Info/441.90, Chemical Info/2H-1-Benzopyran-2-methanol, α,α′-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro]-, hydrochloride, (αR,α′R,2R,2′S)-rel-;, Chemical Info/(1RS,1′RS)-1,1′-[(2RS,2′SR)-Bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2′-iminodiethanol hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Spectroscopic Identification Tests <197>, Infrared Spectroscopy, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, IMPURITIES/Stereoisomeric Purity, IMPURITIES/Content of Nebivolol Related Compound C and Nebivolol Related Compound D (if present), SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nebivolol Stereoisomers Mixture RS Donald Min
Revision NEOMYCIN SULFATE PF 44(6) Pg. ONLINE
Chemical Info/Chemical NameChemical Info/Chemical StructureChemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., SPECIFIC TESTS/Composition of Neomycin Sulfate, SPECIFIC TESTS/Sterility Tests <71>, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neomycin A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neomycin B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Neomycin Sulfate System Suitability Mixture RS Julie Zhang
New NILOTINIB PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C28H22F3N7O·HCl·H2O, Chemical Info/584.00, Chemical Info/Benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino, monohydrochloride, monohydrate;, Chemical Info/4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyridin-3-yl)pyrimidin-2-yl]amino}benzamide hydrochloride monohydrate, Chemical Info/CAS, Chemical Info/C28H22F3N7O, Chemical Info/529.52, Chemical Info/Free base, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197M>, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Nilotinib Related Compound A, Nilotinib Related Compound B, and Nilotinib Related Compound C, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nilotinib System Suitability Mixture RS Feiwen Mao
Title, Chemical Info/Chemical Structure, Chemical Info/C20H24N2O6, Chemical Info/388.41, Chemical Info/3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, (±)-;, Chemical Info/(±)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nifedipine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nisoldipine Related Compound G RS Donald Min
New NITAZOXANIDE PF 44(4) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C12H9N3O5S, Chemical Info/307.28, Chemical Info/2-(Acetyloxy)-N-(5-nitro-2-thiazolyl) benzamide;, Chemical Info/N-(5-Nitrothiazol-2-yl)salicylamide acetate ester, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Aspirin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nitazoxanide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nitazoxanide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Nitazoxanide Related Compound B RS Shankari Shivaprasad
IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature<741>, Class I, SPECIFIC TESTS/Limit of Ethynyl Group, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Norgestrel Related Compound L RS Ren-Hwa Yeh
New OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES PF 44(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sodium, IDENTIFICATION/D. Identification Tests-General <191>, Chemical Identification Tests, Bicarbonate, ASSAY/Procedure for Omeprazole, ASSAY/Procedure for Sodium Bicarbonate, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Acid-Neutralizing Capacity <301>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound F and G Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound I RS Richard Nguyen
NewOMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION PF 44(3) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General <191>, Chemical Identification Tests, Sodium, IDENTIFICATION/D. Identification Tests-General <191>, Chemical Identification Tests, Bicarbonate, ASSAY/Procedure for Omeprazole, ASSAY/Procedure for Sodium Bicarbonate, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, Content Uniformity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Acid-Neutralizing Capacity <301>, SPECIFIC TESTS/Microbial Enumeration Tests <61> and Tests for Specified Microorganisms <62>, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound F and G Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Omeprazole Related Compound I RS Richard Nguyen
IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, IMPURITIES/Limit of Oxycodone Related Compound B (Oxycodone N-Oxide), ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxycodone Related Compound B RS Hillary Cai
Revision OXYMETHOLONE PF 44(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption <197K>Spectroscopic Identification Tests <197>, Infrared Spectroscopy, IDENTIFICATION/B. Ultraviolet Absorption <197U>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, SPECIFIC TESTS/Completeness of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxymetholone Related Compound B RS Ren-Hwa Yeh
Revision OXYMETHOLONE TABLETS PF 44(6) Pg. ONLINE
IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Oxymetholone Related Compound B RS Ren-Hwa Yeh
Revision PACLITAXEL INJECTION PF 44(6) Pg. ONLINE
IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Procedure: Limit of Degradation Products, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Paclitaxel Related Compound B RS Feiwen Mao
Revision PAMABROM PF 43(2) Pg. ONLINE
IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test <201>, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/8-Bromotheophylline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pamabrom Related Compound A RS Clydewyn Anthony
Revision PENTAZOCINE AND NALOXONE TABLETS PF 45(1) Pg. ONLINE
:, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage: Hillary Cai
Revision PETROLATUM PF 45(3) Pg. ONLINEPetrolatum/IDENTIFICATION, Petrolatum/IMPURITIES, Petrolatum/SPECIFIC TESTS, Petrolatum/ADDITIONAL REQUIREMENTS Kevin Moore
Revision WHITE PETROLATUM PF 45(3) Pg. ONLINEWhite Petrolatum/IDENTIFICATION, White Petrolatum/IMPURITIES, White Petrolatum/SPECIFIC TESTS, White Petrolatum/ADDITIONAL REQUIREMENTS Kevin Moore
:, CONTAMINANTS/Absence of Specified Microorganisms
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, Methods of Analysis, Foreign Organic Matter:, SPECIFIC TESTS/Articles of Botanical Origin
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, Methods of Analysis, Alcohol-Soluble Extractives, Method 1:, SPECIFIC TESTS/Articles of Botanical Origin
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:, CONTAMINANTS/Absence of Specified Microorganisms
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, Methods of Analysis, Foreign Organic Matter:, SPECIFIC TESTS/Articles of Botanical Origin
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, Methods of Analysis, Total Ash:, SPECIFIC TESTS/Articles of Botanical Origin
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, Methods of Analysis, Acid-Insoluble Ash:, SPECIFIC TESTS/Water Determination
Michael ChangRevision POTASSIUM CARBONATE PF 45(1) Pg. ONLINE ASSAY/Procedure Michael Chang
RevisionPOTASSIUM CHLORIDE IN LACTATED RINGER'S AND DEXTROSE INJECTION PF 45(2) Pg. ONLINE
IDENTIFICATION/B. Identification Tests—General 191 , Chemical Identification Tests, Chloride and Calcium:, ASSAY/Lactate, IMPURITIES/Limit of 5-Hydroxymethylfurfural and Related Substances Ren-Hwa Yeh
IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test <85>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Propranolol Related Compound A RS Donald Min
Chemical Info/Chemical Name (1S,2S)-2-(Methylamino)-1-phenylpropan-1-ol, IDENTIFICATION/A. Infrared Absorption <197K><197>, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature <741>, Class I Clydewyn Anthony
IDENTIFICATION/A. Melting Range or Temperature 741 , Class I, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Reaction, ADDITIONAL REQUIREMENTS/USP Reference Standards
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound B RS Claire Chisolm
New PYRIDOSTIGMINE BROMIDE EXTENDED-RELEASE TABLETS PF 44(2) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Bromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Pyridostigmine Related Compound B RS Claire Chisolm
Revision QUINAPRIL TABLETS PF 44(4) Pg. ONLINE
IDENTIFICATION/Thin-Layer Chromatographic Identification Test <201>, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Quinapril Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Quinapril Related Compound B RS Donald Min
Title, Chemical Info/Chemical Structure, Chemical Info/C21H15ClF4N4O3·H2O, Chemical Info/500.83, Chemical Info/2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]-3-fluorophenoxy]-N-methyl-, monohydrate;, Chemical Info/4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, Chemical Info/C21H15ClF4N4O3, Chemical Info/482.82, DEFINITION/Introduction, IDENTIFICATION/A. Spectroscopic Identification Tests <197>, Infrared Spectroscopy, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Regorafenib Related Compound A, SPECIFIC TESTS/Water Determination <921>, Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Regorafenib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Regorafenib Related Compound A RS 4-(4-Amino-3-fluorophenoxy)-N-methylpicolinamide.C13H12FN3O2261.26, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sorafenib Tosylate RS 1-[4-Chloro-3-(trifluoromethyl)phenyl]-3-(4-{[2-(methylcarbamoyl)pyridin-4-yl]oxy}phenyl}urea mono(4-methylbenzenesulfonate).C21H16ClF3N4O3·C7H8O3S637.03 Feiwen Mao
New REPAGLINIDE AND METFORMIN HYDROCHLORIDE TABLETS PF 44(5) Pg. ONLINE
Revision LACTATED RINGER'S INJECTION PF 45(2) Pg. ONLINEIDENTIFICATION/A. Identification Tests—General 191 , Chemical Identification Tests, Chloride and Calcium:, ASSAY/Chloride, SPECIFIC TESTS/Sterility Tests
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Revision LACTATED RINGER'S AND DEXTROSE INJECTION PF 45(2) Pg. ONLINE
IDENTIFICATION/B. Identification Tests—General 191 , Chemical Identification Tests, Chloride and Calcium:, ASSAY/Chloride, ASSAY/Dextrose, IMPURITIES/Limit of 5-Hydroxymethylfurfural and Related Substances, SPECIFIC TESTS/Sterility Tests
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RevisionHALF-STRENGTH LACTATED RINGER'S AND DEXTROSE INJECTION PF 45(2) Pg. ONLINE
IDENTIFICATION/B. Identification Tests—General 191 , Chemical Identification Tests, Chloride and Calcium:, ASSAY/Chloride, ASSAY/Dextrose, SPECIFIC TESTS/Sterility Tests
IDENTIFICATION/B. Identification Tests—General 191 , Chemical Identification Tests, Chloride and Calcium:, ASSAY/Calcium, ASSAY/Chloride, ASSAY/Dextrose, IMPURITIES/Limit of 5-Hydroxymethylfurfural and Related Substances, SPECIFIC TESTS/Sterility Tests
DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2: Limit of Ropivacaine Related Compound A, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Color, SPECIFIC TESTS/Clarity, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ropivacaine Related Compound B RS Ren-Hwa Yeh
CHEMICAL INFORMATION, DEFINITION, IDENTIFICATION/A. Spectroscopic Identification Tests
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, Infrared Spectroscopy:, ASSAY/Total Titratable Amines, OTHER COMPONENTS/Carbonate Content, IMPURITIES/Residue on Ignition
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Donald Min
New SEVELAMER CARBONATE FOR ORAL SUSPENSION PF 45(3) Pg. ONLINE
:, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests
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New SORAFENIB TOSYLATE PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C21H16ClF3N4O3·C7H8O3S, Chemical Info/637.03, Chemical Info/2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-, mono(4-methylbenzenesulfonate);, Chemical Info/4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide mono(4-methylbenzenesulfonate), Chemical Info/CAS, Chemical Info/Sorafenib (free base), Chemical Info/C21H16ClF3N4O3, Chemical Info/464.83, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sorafenib Tosylate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Sorafenib Related Compound H RS Feiwen Mao
IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure for a pooled sample, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Terbutaline Related Compound A RS Ren-Hwa Yeh
Omission TESTOLACTONE PF 45(3) Pg. ONLINE Entire document Feiwen Mao
New TETRABENAZINE PF 44(3) Pg. ONLINE
Title, Chemical Info/Chemical Structure, Chemical Info/C19H27NO3, Chemical Info/317.42, Chemical Info/2-H-Benzo[a]quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-;, Chemical Info/(3RS,11bRS)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying <731>, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetrabenazine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetrabenazine Related Compound C RS Sridevi Ramachandran
Chemical Info/Chemical Structure, Chemical Info/C16H28N4O8, Chemical Info/404.42, Chemical Info/1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetraacetic acid;, Chemical Info/2,2′,2′′,2′′′-(1,4,7,10-Tetraazacyclododecane-1,4,7,10-tetryl)tetraacetic acid., Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197A> or <197K>, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination <921>, Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetraxetan RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tetraxetan Related Compound A RS Ravi Ravichandran
Title, Chemical Info/Chemical Structure, Chemical Info/C23H28F2N6O4S, Chemical Info/522.57, Chemical Info/1,2-Cyclopentanediol, 3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)-, (1S,2S,3R,5S)-;, Chemical Info/(1S,2S,3R,5S)-3-{7-[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropylamino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl}-5-(2-hydroxyethoxy)cyclopentane-1,2-diol, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Spectroscopic Identification Tests <197>, Infrared Spectroscopy, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition <281>, IMPURITIES/Limit of Ticagrelor Related Compound A (if present), IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Requirements <659>, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ticagrelor RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ticagrelor Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Ticagrelor Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/ Donald Min
New TIZANIDINE CAPSULES PF 44(4) Pg. ONLINE
Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tizanidine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tizanidine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Tizanidine Related Compound C RS Sridevi Ramachandran
, SPECIFIC TESTS/Water Activity, CONTAMINANTS/Microbial Enumeration Tests
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:, CONTAMINANTS/Absence of Specified Microorganisms
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, Methods of Analysis, Foreign Organic Matter:, SPECIFIC TESTS/Articles of Botanical Origin
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561
⟩
, Methods of Analysis, Water-Soluble Extractives, Method 2:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Total Ash:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Acid-Insoluble Ash:, SPECIFIC TESTS/Loss on Drying
DEFINITION, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin
⟨
203
⟩
, IDENTIFICATION/B. HPLC, COMPOSITION/Content of Caffeoylquinic Acids and Flavone Glycosides, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Limits of Elemental Impurities:, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Pesticide Residue Analysis:, CONTAMINANTS/Articles of Botanical Origin
⟨
561
⟩
, Test for Aflatoxins:, CONTAMINANTS/Microbial Enumeration Tests
⟨
2021
⟩
:, CONTAMINANTS/Absence of Specified Microorganisms
⟨
2022
⟩
, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli:, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Alcohol-Soluble Extractives, Method 1:, SPECIFIC TESTS/Articles of Botanical Origin ⟨
561
⟩
, Methods of Analysis, Water-Soluble Extractives, Method 2:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Total Ash:, SPECIFIC TESTS/Articles of Botanical Origin
⟨
561
⟩
, Methods of Analysis, Acid-Insoluble Ash:, SPECIFIC TESTS/Loss on Drying
IDENTIFICATION/A. Spectroscopic Identification Tests 197 , Infrared Spectroscopy:, ASSAY/Procedure, IMPURITIES/Limit of Triphenylmethanol and Other Impurities, IMPURITIES/Limit of Zidovudine Related Compounds B and C, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Triphenylmethanol, ADDITIONAL REQUIREMENTS/USP Reference Standards